A concordance analysis from ADAPTABLE, a large pragmatic, comparative effectiveness trial, found low to moderate agreement between patient-reported health data and data derived from the electronic health record (EHR). The findings highlight the need for better integration of patient-reported health data into pragmatic research studies. Results of the study were published in JAMA Cardiology. Patient-reported health data ...

The Health Care Systems Research Network (HCSRN) opened registration and announced the opening plenary speaker for its 2023 annual conference in Denver, Colorado. This year’s opening plenary session will feature keynote speaker Dr. Abdul Shaikh, population health analytics leader for the worldwide public sector at Amazon Web Services (AWS). New and emerging approaches to using AI/ML, ...

In this Friday’s PCT Grand Rounds, Dr. Padmanabhan Ramnarayan of Imperial College London will present “The FIRST-ABC Pragmatic Trials of Non-Invasive Respiratory Support in Children.” The Grand Rounds session will be held on Friday, November 18, 2022, at 1:00 pm eastern. Ramnarayan is a reader in pediatric critical care at Imperial College London. FIRST-ABC is a ...

This Friday’s PCT Grand Rounds will feature the next installment of our special series, Ethical & Regulatory Dimensions of Pragmatic Clinical Trials. Stephanie Morain and Kayte Spector-Bagdady will present “Data Sharing and Pragmatic Clinical Trials: Law and Ethics Amidst a Changing Policy Landscape.” The Grand Rounds session will be held on Friday, November 11, 2022, at ...

The NIH Pragmatic Trials Collaboratory will offer a full-day workshop at the 15th Annual Conference on the Science of Dissemination and Implementation in Health in Washington, DC. The workshop, “Dissemination & Implementation Research Methods and Embedded Pragmatic Trials: Strategies for Designing Studies That Inform Care for Diverse Populations,” will introduce concepts in the design, conduct, ...

In this Friday’s PCT Grand Rounds, Dr. Amit Goyal of the Cleveland Clinic will present “The CardioNerds Clinical Trials Network: Pairing Equitable Enrollment With Trainee Development.” The Grand Rounds session will be held on Friday, November 4, 2022, at 1:00 pm eastern. Goyal is a fellow in interventional/structural cardiology at the Cleveland Clinic and a cofounder ...

The NIH Pragmatic Trials Collaboratory will offer a full-day preconference workshop at the 2023 Health Care Systems Research Network (HSCRN) Annual Conference in Denver, Colorado. This year’s conference theme is “Leveraging the Power of the Network in Rapidly Changing Times.” The NIH Collaboratory workshop, “Changing Trials for Changing Times: Essentials of Embedded Pragmatic Clinical Trials,” will ...

In this Friday’s PCT Grand Rounds, Emily O’Brien of Duke University and Russell Rothman of Vanderbilt University will present “The HERO (Healthcare Worker Exposure Response & Outcomes) Program: An Online Community to Support Observational Studies, Randomized Trials, and Long-Term Safety Surveillance.” The Grand Rounds session will be held on Friday, October 28, 2022, at 1:00 ...

The NIH Pragmatic Trials Collaboratory is pleased to announce the addition of 2 new Core Working Groups that will be focused on implementation science and health equity. The Implementation Science Core will provide technical support and pragmatic trial expertise for NIH Collaboratory Trials with a specific focus on innovative dissemination and implementation science approaches. The Core ...

Abstract submissions and panel presentation submissions for the Health Care Systems Research Network (HCSRN) 2023 Annual Conference are due this Friday, October 21. The conference will be held in Denver, Colorado, from February 21 to 23, 2023. The HCSRN is a 20-member research network focused on supporting research institutes aligned with healthcare delivery systems. The HCSRN’s ...

In this Friday’s PCT Grand Rounds, Eric Perakslis of Duke University and Andrea Downing of The Light Collective will present “Disinformation, Cyberthreat, and Choice: Protecting Patients and Clinical Research From the Digital Triple Threat.” The Grand Rounds session will be held on Friday, October 21, 2022, at 1:00 pm eastern. A professor of population health sciences ...

The NIH Pragmatic Trials Collaboratory announced the addition of a new collection in the Living Textbook of Pragmatic Clinical Trials focused on ethical and regulatory aspects of pragmatic trials. “The Living Textbook is a dynamic, evolving collection of knowledge gained from 10 years of conducting pragmatic clinical trials within the NIH Collaboratory,” said Dr. Kevin Weinfurt, ...

Rachel Richesson, cochair of the NIH Pragmatic Trials Collaboratory’s Electronic Health Records (EHR) Core, will present this week at IMPACT Collaboratory Grand Rounds. The virtual session, “Developing Standards and Quality Metrics for Clinical Phenotyping Using EHR Data in Pragmatic Clinical Trials,” will be held on Thursday, October 20, 2022, at 12:00 pm eastern. Richesson is a professor ...

The National Institute of Nursing Research (NINR) will host a webinar for its recent request for applications, “RFA-NR-23-001, HEAL Initiative: Prevention and Management of Chronic Pain in Rural Populations (UG3/UH3 Clinical Trial Required).” The webinar will describe key features of the funding opportunity, review the interests of participating Institutes and Centers, and address questions from ...

This Friday’s PCT Grand Rounds will feature the next installment of our special Grand Rounds series, Ethical & Regulatory Dimensions of Pragmatic Clinical Trials. Joe Ali, Tanya Matthews, and Leslie Crofford will present “Responding (or Not) to Signals of Potential Clinical Significance in Pragmatic Clinical Trials.” The Grand Rounds session will be held on Friday, October ...

The Agency for Healthcare Research and Quality (AHRQ) announced a new competition to explore the feasibility, resources, and infrastructure needed to integrate real-world healthcare system data into the agency’s systematic review findings to improve healthcare practice. The top award winner could earn up to $200,000. Learn more about AHRQ’s Challenge on Integrating Healthcare System Data With ...

The Health Care Systems Research Network (HCSRN) has extended to October 21 the deadline for abstract submissions and panel presentation submissions for its 2023 Annual Conference. The conference will be held in Denver, Colorado, from February 21 to 23, 2023. The HCSRN is a 20-member research network focused on supporting research institutes aligned with healthcare delivery ...

In this Friday’s PCT Grand Rounds, Dr. Melanie Meersch-Dini of University Hospital Münster (Germany) will present “Impact of Handovers of Anesthesia Care on Morbidity and Mortality.” The Grand Rounds session will be held on Friday, October 7, 2022, at 1:00 pm eastern. Dr. Meersch-Dini will discuss the results of the HandiCAP trial (Impact of Handover of ...

The Health Care Systems Research Network (HCSRN) is accepting abstract submissions and panel presentation submissions for its 2023 Annual Conference until October 7, 2022. The conference will be held in Denver, Colorado, from February 21 to 23, 2023. The HCSRN is a 20-member research network focused on supporting research institutes aligned with healthcare delivery systems. The ...

In this Friday’s PCT Grand Rounds, Marianne Chase of Massachusetts General Hospital and Dr. Jörg Goldhahn of ETH Zurich will present “CTTI’s Digital Health Trials Hub: Multi-Stakeholder Resources to Conduct Effective Digital Health Trials.” The Grand Rounds session will be held on Friday, September 30, 2022, at 1:00 pm eastern. Chase is senior director for clinical ...

The NIH Pragmatic Trials Collaboratory will offer a full-day workshop at the 15th Annual Conference on the Science of Dissemination and Implementation in Health in Washington, DC. The workshop, “Dissemination & Implementation Research Methods and Embedded Pragmatic Trials: Strategies for Designing Studies That Inform Care for Diverse Populations,” will introduce concepts in the design, conduct, ...

In this Friday’s PCT Grand Rounds, Dr. Margaret McConnell of the Harvard T.H. Chan School of Public Health will present “Effect of an Intensive Nurse Home Visiting Program on Adverse Birth Outcomes in a Medicaid-Eligible Population.” The Grand Rounds session will be held on Friday, September 23, 2022, at 1:00 pm eastern. Dr. McConnell is an ...

The Johns Hopkins Berman Institute of Bioethics this week opened the application period for its 2023-2024 postdoctoral fellowships, including a Postdoctoral Fellowship in the Ethics and Regulatory Aspects of Pragmatic Clinical Trials. From the announcement: The Johns Hopkins Berman Institute of Bioethics invites applications for a Postdoctoral Fellowship in the Ethics and Regulatory Aspects of Pragmatic Clinical ...

In this Friday’s PCT Grand Rounds, Dr. Tor Biering-Sørensen of the University of Copenhagen will present “Using Nationwide Registries to Conduct Pragmatic Randomized Trials: The DANFLU Program.” The Grand Rounds session will be held on Friday, September 16, 2022, at 1:00 pm eastern. Dr. Biering-Sørensen is professor and head of the Center for Translational Cardiology and ...

The deadline to submit letters of intent for the NIA IMPACT NIH Collaboratory Trials Program has been extended to September 30, 2022. This summer, the IMPACT Collaboratory announced a request for applications for its NIH Collaboratory Trials Program.  This funding mechanism supports large-scale pragmatic clinical trials embedded in healthcare systems to test the effectiveness of nonpharmacological ...

In this Friday’s PCT Grand Rounds, Dr. Steve Joffe will kick off our special Grand Rounds series, Ethical & Regulatory Dimensions of Pragmatic Clinical Trials, with a keynote presentation, “Building an Academic Learning Health System: Why Is It So Hard?” The Grand Rounds session will be held on Friday, September 9, 2022, at 1:00 pm ...

The Health Care Systems Research Network (HCSRN) is accepting abstract submissions and panel presentation submissions for its 2023 Annual Conference until October 7, 2022. This year’s meeting will be held in Denver, Colorado, from February 21 to 23, 2023. The HCSRN is a 20-member research network focused on supporting research institutes aligned with healthcare delivery systems. ...

A new section of the NIH Pragmatic Trials Collaboratory’s Living Textbook of Pragmatic Clinical Trials discusses challenges associated with Evaluating Fitness for Use of real-world data for trials. The section uses a case study from the Harmony Outcomes EHR Ancillary Study (eHARMONY) to describe lessons learned and to provide recommendations for studies considering incorporating real-word data as ...

The US Food and Drug Administration (FDA) will host a webinar on September 9 for industry, patient groups, and other interested stakeholders to discuss and answer questions about the draft guidance, Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments. The draft guidance, known as “Guidance 3,” is the third of 4 methodological guidance ...

The NIH Pragmatic Trials Collaboratory is launching a special Grand Rounds series to examine ethical and regulatory challenges in pragmatic clinical trials. Over the past decade, the program’s Ethics and Regulatory Core has worked with investigators to navigate ethical and regulatory complexities associated with research conducted within healthcare systems. With this new Grand Rounds series, ...

In this Friday’s PCT Grand Rounds, Dr. Areef Ishani of the University of Minnesota will present “The Diuretic Comparison Project: A Large Pragmatic Clinical Trial.” The Grand Rounds session will be held on Friday, August 26, 2022, at 1:00 pm eastern. The Diuretic Comparison Project is a large, national “point-of-care clinical trial” comparing the effects of ...

The NIH Pragmatic Trials Collaboratory is pleased to announce that the IMPACt-LBP NIH Collaboratory Trial received approval this month to transition from the planning phase to the implementation phase. This pragmatic clinical trial embedded in healthcare systems is studying implementation of guideline-based care for low back pain, a leading cause of ambulatory care visits in ...

The NIH HEAL Initiative℠, or Helping to End Addiction Long-Term Initiative℠, announced its intent to publish a new funding opportunity for cooperative research that will accelerate implementation of nonopioid interventions for chronic pain management in rural and remote populations. The initiative will support pragmatic, implementation, and hybrid effectiveness-implementation trials that study strategies for equitably and ...

In this Friday’s PCT Grand Rounds, Dr. Gerald Bloomfield and Dr. Michelle Kelsey will present “Inclusion and Diversity in Clinical Trials: Actionable Steps to Drive Lasting Change.” The Grand Rounds session will be held on Friday, August 19, 2022, at 1:00 pm eastern. Dr. Bloomfield is an associate professor of medicine and global health and Dr. ...

In an interview at the NIH Pragmatic Trials Collaboratory’s annual Steering Committee meeting and 10th anniversary celebration, we asked Dr. Liz Turner and Dr. Patrick Heagerty to reflect on the role of the Biostatistics and Study Design Core Working Group in helping the NIH Collaboratory Trial teams design their trials and analyze the data, and ...

The Helping to End Addiction Long-Term Initiative℠, or NIH HEAL Initiative℠, recently published 2 funding opportunity announcements soliciting applications focused on sickle cell disease (SCD) pain management. The effort is co-led by the National Center for Complementary and Integrative Health and the National Heart, Lung, and Blood Institute, with support from other NIH Institutes, Centers, ...

The NIH Pragmatic Trials Collaboratory is launching a special Grand Rounds series to examine ethical and regulatory challenges in pragmatic clinical trials. Over the past decade, the program’s Ethics and Regulatory Core has worked with investigators to navigate ethical and regulatory complexities associated with research conducted within healthcare systems. With this new Grand Rounds series, ...

In this Friday’s PCT Grand Rounds, Dr. Consuelo Wilkins of Vanderbilt University will present “Equitably Including Diverse Participants in Pragmatic Clinical Trials.” The Grand Rounds session will be held on Friday, August 12, 2022, at 1:00 pm eastern. Dr. Wilkins is senior vice president and senior associate dean for health equity and inclusive excellence and a ...

The Helping to End Addiction Long-Term Initiative℠, or NIH HEAL Initiative℠, is seeking applications for opioid misuse prevention research in community health centers. The funding opportunity announcement, RFA-DA-23-048: HEAL Initiative: Research Studies to Develop and Implement Interventions to Prevent Opioid Misuse in Community Health Centers, supports interdisciplinary teams to study the development, adaptation, and/or implementation of ...

In this Friday’s PCT Grand Rounds, Dr. Jay JH Park of McMaster University will present “Economic Evaluation of Platform Trial Designs.” The Grand Rounds session will be held on Friday, August 5, 2022, at 1:00 pm eastern. Dr. Park is director of the Platform Trials Initiative in the Canadian Critical Care Trials Group and an assistant ...

The NIA IMPACT Collaboratory announced requests for applications for 2 new funding opportunities: the Pilot Grant Program and the NIH Collaboratory Trials Program.  These programs support research and training to increase the nation’s capacity to conduct pragmatic clinical trials of nonpharmacological interventions within healthcare systems to improve care for people living with Alzheimer disease related ...

In an interview at the NIH Pragmatic Trials Collaboratory Steering Committee meeting in April, Drs. Robin Boineau and Helene Langevin discussed the impact of the NIH Pragmatic Trials Collaboratory on research across the NIH. “The NIH Pragmatic Trials Collaboratory really has been a fertile ground across NIH,” said Boineau, who is the director of the Office ...

In this Friday’s COVID-19 Grand Rounds, Dr. Edward Mills of McMaster University and Dr. Jeffrey Glenn of Stanford University will present “Effect of Early Treatment With Single-Dose Pegylated Interferon Lambda Among Patients With COVID-19: Results From The TOGETHER Trial.” The TOGETHER trial is a randomized adaptive platform trial investigating several treatments for COVID-19. The Grand Rounds session ...

At this year’s annual meeting of the NIH Pragmatic Trials Collaboratory Steering Committee, we interviewed investigators from 3 NIH Collaboratory Trials in different phases of the trial life cycle. IMPACt-LBP launched last fall and is completing its 1-year planning phase. ACP PEACE is nearing the end of its implementation phase. SPOT ended last year and ...

In this Friday’s COVID-19 Grand Rounds, Dr. Susanna Naggie of Duke University will present “ACTIV-6: One Year Later and Trial Results for Ivermectin-400 and Inhaled Fluticasone.” ACTIV-6 is a nationwide, double-blind study evaluating the effectiveness of repurposed medications in reducing symptoms of mild to moderate COVID-19 in outpatients. The Grand Rounds session will be held on Friday, ...

At the NIH Pragmatic Trials Collaboratory’s annual Steering Committee meeting this spring, we interviewed investigators from 3 of the PRISM NIH Collaboratory Trials to discuss their progress in the first year of study implementation. All of the studies began enrollment last year. The PRISM program (Pragmatic and Implementation Studies for the Management of Pain to Reduce ...

Investigators planning emergency department (ED)­–based pragmatic clinical trials (PCTs) face multiple decisions during the planning phase to ensure robust and meaningful study findings in this unique setting; however, there is no guide for planning and conducting these studies. A new article in Academic Emergency Medicine fills the gap by providing recommendations for the design of PCTs ...

In the latest episode of the NIH Collaboratory Grand Rounds podcast, Dr. John Concato and Dr. Richard Platt continue their discussion about the FDA draft guidance on real-world evidence. The full June 24 Grand Rounds webinar with Dr. Concato is also available.

During the NIH Pragmatic Trials Collaboratory Steering Committee meeting and 10th anniversary celebration, Dr. Keith Marsolo, Co-chair of the Electronic Health Records Core, moderated a panel on “Barriers and Challenges: Data Collection and Merging Datasets.” Four panelists shared their experiences collecting and aggregating data from diverse data sets and how they solved unexpected challenges. The panelists included ...

In this Friday’s COVID-19 Grand Rounds, Dr. Stacey Adam of the Foundation for the NIH will present “Overview of Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Public-Private Partnership and Lessons Learned.” The NIH announced the ACTIV public-private partnership in April 2020 to develop a coordinated research strategy for speeding development of COVID-19 treatments and vaccines. The ...